By InvitationNot Applicable

Evaluation of a Mobile Application Designed to Support Type 1 Diabetic Patients in Adjusting Their Insulin Doses.

Iraq50 participantsStarted 2025-09-01

Plain-language summary

Title: Evaluating a Mobile Application for Insulin Management in Iraqi Type 1 Diabetes Patients. The goal of this clinical trial is to determine whether a mobile health application can improve insulin management and blood sugar control in Iraqi patients with Type 1 Diabetes aged over 15 years who are on intensive insulin therapy. The main question it aims to answer is: Does the use of the mobile application lead to a greater reduction in HbA1c levels compared to standard care alone? Researchers will compare the group using the mobile application to the group receiving standard care alone to see if the application is more effective at improving glycemic control. Participants will: Be randomly assigned to one of two groups for the 3-month study. Either use the mobile application to guide their daily insulin dose adjustments alongside standard care, or receive standard care alone. Undergo blood tests (including HbA1c) and complete questionnaires about hypoglycemic events, insulin adherence, and quality of life.

Who can participate

Age range15 Years

SexALL

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Inclusion criteria

✓. Patients (≥15 years), with uncontrolled (HbA1c ≥ 7) type 1 diabetes who were treated with multiple daily insulin injections (MDI) for at least 3 months before the study date.
✓. Patients who are willing to test their blood glucose level at least 3 times daily during the study period.
✓. Participants who will give their informed consent to participate in the study. -

Exclusion criteria

✕. Pregnant woman or planning to be pregnant
✕. Patients at high risk of developing hypoglycemia (e.g., those with IHD, osteoporosis, hypoglycemia unawareness).
✕. Patients with psychiatric disorders.
✕. Patients who will be subjected to a major change in insulin dose (more than 20%) at the start or during the study period.
✕. Patients who don't use the application during the study period. The usage Metrics of the application will be watched on Google Analytics

What they're measuring

Change in Glycated Hemoglobin (HbA1c)

Timeframe: Baseline (Day 0) and Post-intervention (Month 3)

Trial details

NCT IDNCT07234500

SponsorUniversity of Baghdad

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Type One Diabetes Mellitus trials